Orange County medical device makers are awaiting the outcome of closed door talks between the Food and Drug Administration and industry officials about a user-fee program they contend hasn’t worked.
Device makers started paying fees in 2003 as a way to help improve the review process for their products by funding more FDA staffers.
Executives polled by the FDA earlier this year said the user fees haven’t resulted in faster, more reliable product approvals.
Industry officials and the FDA now are evaluating the program, in which fees have shot up more than 80% since it began in 2003.
Starting in 2007, large companies are set to pay $281,000 per application, up from $154,000 in 2003.
Small companies, device makers with less than $30 million in revenue, are expected to pay $107,008 per application.
Some have suggested scrapping the user-fee program. But some device makers say paying fees isn’t the issue.
“We do expect improved performance,” said Andy Stapars, vice president of global public policy for Santa Ana-based eye products maker Advanced Medical Optics Inc.
Patricia Garvey, who recently retired from Irvine heart valve maker Edwards Lifesciences Corp. to become vice president at industry group AdvaMed, told the Associated Press that there was “a real consensus among industry that we haven’t seen the type of performance we expected.”
For more on this story, see the Nov. 20 edition of the Business Journal.
